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Phase I First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms

Summary

NOTE: This trial currently has a waiting list. The purpose of this phase I study is to evaluate the safety of MGD009 (orlotamab) when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Biomarker testing to determine if patient is eligible for the trial will be done during prescreening for the trial.

General Information

NCT#: NCT02628535
Study ID: CP-MGD009-01
Trial Phase: Phase I

Trial Sponsor: MacroGenics
Therapies Used in This Trial: Orlotamab

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